Patent Grant
10646118
The present application is related to U.S. patent application Ser. No. 14/586,529, entitled “LASER CATHETER WITH USE OF DETERMINED MATERIAL TYPE IN VASCULAR SYSTEM IN ABLATION OF MATERIAL,” which is filed on the same day as the present application and the contents of which are incorporated by reference herein for all that it discloses. The present application is also related to U.S. patent application Ser. No. 14/586,543, entitled “LASER CATHETER WITH USE OF REFLECTED LIGHT AND FORCE INDICATION TO DETERMINE MATERIAL TYPE IN VASCULAR SYSTEM,” which is filed on the same day as the present application and the contents of which are incorporated by reference herein for all that it discloses.
The present disclosure relates generally to medical devices, and, more particularly, to laser catheters used in treatment within a vascular system and the use of reflected light associated with a laser catheter to determine a type of a material within a vascular system.
Electrical leads, such as those used with pacemakers, defibrillators, etc., are implanted in the human vascular system and often experience a buildup of unwanted deposits thereon, such as plaque, calcified tissue, and the like. Additionally, human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, emboli, etc., which reduce the blood carrying capacity of such vessels. Should a blockage occur at a critical place in the vascular system of a patient, serious and permanent injury, and even death, can occur. To prevent damage to electrical leads, and to prevent damage elsewhere in the vascular system, some form of medical intervention is usually performed when a buildup or significant occlusion is detected.
Laser-based catheter devices are often used to ablate such buildups or occlusions. Laser light is sent down optical fibers of a laser catheter to perform laser ablation and, in some cases, visualization of vascular structure. Additionally, fluoroscopy presents a two-dimensional view and, in cases where contrast agents are injected, provides indirect visualization of vascular structure. Fluoroscopy is a procedure that may introduce undesirable radiation exposure and risks associated with the use of contrast agents, and may also provide insufficient imaging or feedback for clinicians to clearly understand the interface between the catheter device and the vascular system. As a result, with a fluoroscopy procedure, there is a risk of errors in determining whether or not contacted tissue should be ablated, errors in determining how much undesired tissue remains during or after ablation, and potential overtreatment including tearing of tissue.
These and other needs are addressed by the various aspects, embodiments, and configurations of the present disclosure.
According to one embodiment of the present disclosure, an apparatus for determining a type of a material in a region within a vascular system of a patient may include a laser catheter and at least one controller. The laser catheter may be coupled to a light source and may include at least one source fiber configured to supply light from the light source to a region within a vascular system of a patient so as to illuminate the region within the vascular system of the patient. The laser catheter may also include at least one return fiber configured to receive light reflected from the region within the vascular system of the patient, where the reflected light may be indicative of at least one of a transmittance, a reflectance, an absorbance, and a scattering coefficient of the region within the vascular system of the patient. The at least one controller may be configured to determine the at least one of the transmittance, the reflectance, the absorbance, and the scattering coefficient of the region within the vascular system of the patient. The at least one controller may be further configured to determine a type of a material in the region within the vascular system based on determining the at least one of the transmittance, the reflectance, the absorbance, and the scattering coefficient of the region within the vascular system.
According to another embodiment of the present disclosure, an apparatus for determining a type of a material in a region within a vascular system of a patient and a distance to the material may include a laser catheter and at least one controller. The laser catheter may be coupled to a light source and may include at least one source fiber configured to supply light from the light source to a region within a vascular system of a patient so as to illuminate the region within the vascular system of the patient. The laser catheter may also include at least one return fiber configured to receive light reflected from the region within the vascular system of the patient. The at least one controller may be configured to determine at least one property of the region within the vascular system from the reflected light from the region within the vascular system. The at least one controller may also be configured to determine a type of a material in the region within the vascular system based on determining the at least one property from the reflected light. The at least one controller may be further configured to determine an indication of a distance to the material in the region within the vascular system based on determining the at least one property from the reflected light.
According to yet another embodiment of the present disclosure, a method for determining a type of a material in a region within a vascular system of a patient may include receiving an output from at least one return fiber of a laser catheter, where the at least one return fiber receives light reflected from a region within a vascular system of a patient after at least one source fiber has supplied light to the region. The reflected light may be indicative of at least one of a transmittance, a reflectance, an absorbance, and a scattering coefficient of the region within the vascular system of the patient. The method may also include determining the at least one of the transmittance, the reflectance, the absorbance, and the scattering coefficient of the region within the vascular system of the patient. The method may further include determining a type of a material in the region within the vascular system of the patient based on determining the at least one of the transmittance, the reflectance, the absorbance, and the scattering coefficient of the region within the vascular system.
According to another embodiment of the present disclosure, a method for determining a type of a material in a region within a vascular system of a patient and a distance to the material may include receiving an output from at least one return fiber of a laser catheter, where the at least one return fiber receives light reflected from a region within a vascular system of a patient after at least one source fiber has supplied light to the region. The method may also include determining at least one property of the region within the vascular system from the reflected light from the region within the vascular system. The method may further include determining a type of a material in the region within the vascular system based on determining the at least one property from the reflected light. The method may also include determining an indication of a distance to the material in the region within the vascular system based on determining the at least one property from the reflected light.
According to yet another embodiment of the present disclosure, a non-transitory computer-readable medium may include executable instructions that when executed by one or more processors cause the one or more processors to generate, based on light reflected from a region within a vascular system of a patient after illumination of the region with light from a light source, at least one signal indicative of at least one property of the region within the vascular system. The executable instructions, when executed by the one or more processors, may also cause the one or more processors to determine, based on the generated at least one signal, the at least one property of the region within the vascular system. The executable instructions, when executed by the one or more processors, may further cause the one or more processors to determine a type of a material in the region within the vascular system based on determining the at least one property of the region.
These and other advantages will be apparent from the disclosure of the aspects, embodiments, and configurations contained herein.
As used herein, “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as X1-Xn, Y1-Ym, and Z1-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).
It is to be noted that the term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.
The term “automatic” and variations thereof, as used herein, refers to any process or operation done without material human input when the process or operation is performed. However, a process or operation can be automatic, even though performance of the process or operation uses material or immaterial human input, if the input is received before performance of the process or operation. Human input is deemed to be material if such input influences how the process or operation will be performed. Human input that consents to the performance of the process or operation is not deemed to be “material”.
A “catheter” is a tube that can be inserted into a body cavity, duct, lumen, or vessel, such as the vasculature system. In most uses, a catheter is a relatively thin, flexible tube (“soft” catheter), though in some uses, it may be a larger, solid-less flexible—but possibly still flexible—catheter (“hard” catheter).
The term “computer-readable medium” as used herein refers to any storage and/or transmission medium that participate in providing instructions to a processor for execution. Such a medium is commonly tangible and non-transient and can take many forms, including but not limited to, non-volatile media, volatile media, and transmission media and includes without limitation random access memory (“RAM”), read only memory (“ROM”), and the like. Non-volatile media includes, for example, NVRAM, or magnetic or optical disks. Volatile media includes dynamic memory, such as main memory. Common forms of computer-readable media include, for example, a floppy disk (including without limitation a Bernoulli cartridge, ZIP drive, and JAZ drive), a flexible disk, hard disk, magnetic tape or cassettes, or any other magnetic medium, magneto-optical medium, a digital video disk (such as CD-ROM), any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, a solid state medium like a memory card, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read. A digital file attachment to e-mail or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. When the computer-readable media is configured as a database, it is to be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and/or the like. Accordingly, the disclosure is considered to include a tangible storage medium or distribution medium and prior art-recognized equivalents and successor media, in which the software implementations of the present disclosure are stored. Computer-readable storage medium commonly excludes transient storage media, particularly electrical, magnetic, electromagnetic, optical, magneto-optical signals.
A “coupler” or “fiber optic coupler” refers to the optical fiber device with one or more input fibers and one or several output fibers. Fiber couplers are commonly special optical fiber devices with one or more input fibers for distributing optical signals into two or more output fibers. Optical energy is passively split into multiple output signals (fibers), each containing light with properties identical to the original except for reduced amplitude. Fiber couplers have input and output configurations defined as M×N. M is the number of input ports (one or more). N is the number of output ports and is always equal to or greater than M. Fibers can be thermally tapered and fused so that their cores come into intimate contact. This can also be done with polarization-maintaining fibers, leading to polarization-maintaining couplers (PM couplers) or splitters. Some couplers use side-polished fibers, providing access to the fiber core. Couplers can also be made from bulk optics, for example in the form of microlenses and beam splitters, which can be coupled to fibers (“fiber pig-tailed”).
The terms “analyze”, “determine”, “calculate” and “compute”, and variations thereof, as used herein, are used interchangeably and include any type of methodology, process, mathematical operation or technique.
A “laser emitter” refers to an end portion of a fiber or an optical component that emits laser light from a distal end of the catheter towards a desired target or region, which typically comprises tissue.
An optical fiber (or laser active fiber) is a flexible, transparent fiber made of an optically transmissive material, such as glass (silica) or plastic, which functions as a waveguide, or “light pipe”, to transmit light between the two ends of the fiber.
The term “biological material” includes any living cell or cells, and any biomolecule associated with a living cell or cells (i.e., cell-based). Biological material includes both intracellular biomolecules and extracellular biomolecules. Biological material may include, for example, nucleic acids (i.e., RNA and DNA), amino acids (proteins and polypeptides), carbohydrates (e.g., sugars used for glycosylation), polysaccharides, lipids, and combinations thereof. In the context of the cardiovascular system, biological material includes biomolecules associated with the various cell types that make up the vasculature (e.g., endothelial cells and smooth muscle cells), such as cell surface receptors.
The term “non-biological material” includes any material that is not associated with a living cell or cells (i.e., non-cell-based). Non-biological material includes molecules typically found within an atherosclerotic occlusion and not the surrounding cells of the vasculature. Non-biological material found in atherosclerotic occlusions include, for example, fat deposits (e.g., cholesterol monohydrate, cholesterol esters, and phospholipids), fibrous tissue (e.g., fibrin, proteoglycans, collagen), calcium deposits (e.g., calcium oxide, calcium carbonate, calcium phosphates), and remnants of dead cells and cellular debris.
The term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C., Section 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary of the invention, brief description of the drawings, detailed description, abstract, and claims themselves.
It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation as an alternative, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation as an alternative, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.
The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.
Laser catheters typically transmit laser energy through optical fibers housed in a relatively flexible tubular catheter inserted into a body lumen, such as a part of the vasculature, ureter, fallopian tube, and the like to remove obstructions in the lumen. Catheters used for laser angioplasty and other procedures may have a central passageway or tube which receives a guide wire inserted into the body lumen (e.g., vasculature) prior to catheter introduction. The guide wire facilitates the advancement and placement of the catheter to the selected portion(s) of the body lumen for laser ablation of tissue.
Examples of laser catheters or laser sheath are sold by the Spectranetics Corporation under the trade names ELCA™ and Turbo Elite™ (each of which is used for coronary intervention or catheterization such as recanalizing occluded arteries, changing lesion morphology, and facilitating stent placement) and SLSII™ and GlideLight™ (which is used for surgically implanted lead removal). The working (distal) end of a laser catheter typically has a plurality of laser emitters, such as ends of source fibers, which emit energy and ablate the targeted tissue. The opposite (proximal) end of a laser catheter typically has a fiber optic coupler, which connects to a laser system or device or generator including a light source. One such example of a laser system is the CVX-300 Excimer Laser System, which is also sold by the Spectranetics Corporation.
Referring now to
In another embodiment, a separate light source for purposes of determining the type of the material and the distance to the material in the region within the vascular system of the patient, which may at times be referred to as a diagnostic light source, may be included in the laser device 130 and also coupled to the proximal end of the laser catheter 170 by way of, for example, the coupler 140. The diagnostic light source may be any suitable light source and need not be a laser. For example, the diagnostic light source may be or may include one or more light-emitting diodes (LEDs), broadband light source(s) (e.g., halogen light source(s)), xenon flash light source(s), etc. In such an implementation, the laser device 130 may still include at least one treatment light source, which may also be referred to as a therapeutic light source, such as a laser for ablating bodily material such as buildup of plaque, calcium deposits, scar tissue, or the like. The therapeutic/treatment light source may be adjusted (e.g., in intensity, in distance from tissue, etc., as further described below) based on the determined type of the material in the region and/or the distance to the material in the region. It will be understood in light of the following disclosure that references herein to “light source” may include either or both of (e.g., collectively) the therapeutic/treatment light source and a diagnostic light source.
The laser catheter 170 is also connected to at least one controller 180 by any suitable connection, such as, for example, by way of a wired connection via the coupler 140, a return connection portion 172, and if desired a device such as a USB microscope 175 to aid in producing images of the material in the region of the vascular system of the patient and/or other suitable data as discussed below. The laser catheter 170 may also be connected to the at least one controller 180 by any other suitable wired or wireless connection. While illustrated as a computing device, the at least one controller 180 may be implemented, for example, by executing suitable instructions on any suitable processor(s), by at least one digital signal processor, by one or more application-specific integrated circuits (ASICs), or by any other suitable hardware, firmware, or software implementation or any suitable combination of the example implementations described above. In another embodiment, the at least one controller 180 is connected to the laser device 130 and receives and/or analyzes reflected light from a region within the vascular system of the patient, as further described below, after such reflected light is received by the laser device 130. In yet another embodiment, the at least one controller 180 may be internal to the laser device 130.
As also illustrated in
The distal end 202 of the laser catheter 170 may, in some embodiments, include a lumen 206. If the lumen 206 is included in the laser catheter 170, a clinician may insert the laser catheter 170 into the vasculature over a guidewire (not shown) through the lumen 206. It may, however, be preferable for the laser catheter 170 to have a separate guidewire lumen. Incorporation of such a guidewire lumen is generally known to one of ordinary skill in the art, and all such guidewire lumens within the knowledge of one skilled in the art are considered within the scope of the present disclosure. The lumen 206 may also be used to slide the laser catheter 170 over an electrical lead in a lead removal procedure. The lumen may also include one or more fixed and/or removable conduit(s) for additional tools to assist in tissue removal or navigation, such as but not limited to optical coherence tomography (OCT) catheters or intravascular ultrasound (IVUS) catheters. The additional tools may assist in procedures associated with tissue removal or navigation such as saline injection, suction, balloon deployment, and/or use of injectable contrast agents that can amplify the sensed optical contrast of targeted tissue(s) so as to improve the ability to correctly discriminate such tissue(s).
The aforementioned laser emitter(s), as further described below, may be provided in a generally concentric configuration or in any other suitable configuration such as an eccentric configuration. For example, the lumen 206, in embodiments where the laser catheter includes the lumen 206, may be provided substantially concentric with and interior to the laser emitter(s) (and optical fiber(s)), or eccentric with respect to the laser emitter(s), thereby providing a potential conduit or passageway for translocation of materials cut or ablated by the laser emitter(s).
Although
With continued reference to
The laser catheter 170 includes at least one fiber bundle 504, which in turn may include the at least one source fiber 300 configured to supply light from the light source to a region 506 within the vascular system of a patient so as to illuminate the region 506. The region 506 may comprise an electrical lead or leads as discussed above and, in some cases, buildup or deposit of unwanted material on or surrounding the lead(s). The at least one fiber bundle 504 may also include the at least one return fiber 302 configured to receive light reflected from the region 506 and the at least one additional fiber 304 to enable determination of the intensity of the light supplied by the source fiber(s) 300 from the light source. The at least one return fiber (e.g., return fibers 302a-302d) may, for example, be configured to receive the reflected light between pulses of laser light supplied from the light source via the source fiber(s) 300. In another embodiment, the at least one return fiber 302 may be configured to receive the reflected light from the region 506 within the vascular system of the patient where the light source is the diagnostic light source 502. The at least one return fiber 302 may provide the reflected light to the coupler 140, which may in turn provide the reflected light to the at least one controller 180 for analysis as described below.
In various vascular intervention procedures, particularly in lead removal procedures, it may be desirable to control the intensity of light supplied via the source fiber(s) 300 to the region 506 for each individual fiber; that is, on a fiber-by-fiber basis. For example, a typical electrical lead passes through a portion of the superior vena cava (SVC), and the SVC includes a relatively notable bend. In passing the laser catheter 170 through that bend during a lead removal procedure, it may be useful for a clinician to be able to control the amount of laser energy being emitted by the various fibers within the laser ablation catheter. That is, the intensities in individual ones of the source fibers 300 may be varied with respect to one another under control of the laser device 130. This may be done by the clinician or automatically by the device itself. For example, source fibers 300 interior to the bend in the SVC may not need an adjustment of the intensity of light passing therethrough from the light source, but source fibers 300 on the outside portion of the bend in the SVC may need a reduction in the intensity of source light passing therethrough.
Similarly, there may be situations in which a clinician wishes to control, or needs the ability to control, intensities of light supplied by different ones of the source fibers 300 based on the intensities of reflected light received by different ones of the return fibers 302 (which reflected light is discussed in further detail below) in order to avoid vascular tissue tearing and other dangerous or undesirable results. Accordingly, in an embodiment of the present disclosure, intensities of light supplied by various ones of the source fibers 300 near a particular one of the return fibers 302 (e.g., return fiber 302a) may not be adjusted, while intensities of light supplied by various ones of the source fibers 300 near another particular one of the return fibers 302 (e.g., return fiber 302c) may be adjusted, such as when the intensity of reflected light received by the return fiber 302c meets particular conditions such as falling within a color-specific range or ranges of intensity, exceeding color-specific thresholds, etc.
Still further, in an embodiment of the present disclosure, the intensity/intensities of reflected light received by one or more of the return fibers 302 may be used to adjust the intensity/intensities of light supplied by various ones of the source fibers 300 within the laser catheter 170. As just several examples, the intensity of reflected light received by one return fiber (e.g., return fiber 302a) may be used to adjust the intensity of light supplied by source fibers 300 near the one return fiber, the intensity of light supplied by all source fibers 300, or the intensity of reflected light received by more than one of the return fibers 302 may be averaged or weighted in any other suitable manner and similarly used to adjust the intensity of light supplied by some or all of the source fibers 300. Any suitable use of the intensity/intensities of reflected light received by one or more of the return fiber(s) 302 to adjust the intensity of one or more of the source fiber(s) 300 may be implemented. Such suitable uses further include, by way of example, applications such as controlling therapeutic energy based on contacted tissue, e.g., increasing laser energy or selecting different laser types for ablating calcified plaque and decreasing energy for ablating soft plaque.
As shown in
In one embodiment, the optical property sensing logic 515 may be implemented in hardware and may include, for example, at least one of a spectrometer, filtered light sensor(s), charge-coupled device (CCD) array with suitable optics and/or filters, etc. The at least one processor 508 may further include optical property determining logic 516 coupled to the optical property sensing logic 515, and the optical property determining logic 516 may be coupled to material type determining logic 518 and material distance determining logic 520 in order to determine a type of a material in the region 506 within the vascular system of the patient and in order to determine a distance to the material in the region 506, respectively.
Each of the laser device output logic 514 and other logic described herein may be implemented as software by executing suitable instructions on, for example, the at least one processor 508, or by storing executable instructions on a computer-readable medium (e.g., in the at least one memory 510), where the executable instructions are executable by at least one processor such as the at least one processor 508 to cause the at least one processor to perform the actions described herein. The various logic described herein may also be implemented in any other suitable manner, such as but not limited to a hardware implementation or any suitable combination of the example implementations described above. In the case of, for example, a hardware implementation, it will be appreciated from the disclosure herein that the various logic described may be physically distinct from the at least one processor 508. Additionally, in some cases, one or more of the logic elements described herein may be implemented as or considered as a single logic element, such as, for example, the optical property sensing logic 515 and the optical property determining logic 516. For example, the optical property sensing logic 515 and the optical property determining logic 516 may be implemented as or considered as a single logic element that senses optical properties of the reflected light, generates signals indicative of the sensed optical properties, and determines the optical properties based on the generated signals.
The reflected light received from the at least one return fiber 302 may be indicative of at least one of a transmittance, a reflectance, an absorbance, and a scattering coefficient of the region 506 within the vascular system of the patient. As understood by one skilled in the art, transmittance may be expressed as the percentage of incident light (electromagnetic radiation) on a sample (e.g., tissue in the patient's body) at a particular wavelength that is transmitted through the sample. Absorbance may be expressed as the percentage of incident light (electromagnetic radiation) on a sample at a particular wavelength that is absorbed by the sample. Reflectance may be expressed as the percentage of incident light (electromagnetic radiation) on a sample at a particular wavelength that is reflected by the sample. The reflected light received from the at least one return fiber 302 may also be indicative of at least one of a polarization of a tissue in the region 506 and optical coherence tomography data associated with the material in the region 506, and/or these and/or other suitable optical properties of the region 506 may be sampled and indicated by the output of the at least one return fiber 302 to the coupler 140.
The output of the coupler 140, which may be a modified coupler so as to couple both the at least one source fiber 300 and the at least one return fiber 302, and if desired the at least one additional fiber 304 as well, to the laser device 130 and/or the at least one controller 180, may be provided (e.g., as an image or video frame) to the optical property sensing logic 515 as described above. In another embodiment, a coupler separate from the coupler 140 (which separate coupler is not shown) may couple, for example, the at least one return fiber 302 and, in some cases, the at least one additional fiber 304 to, for example, the at least one controller 180.
The optical property sensing logic 515 may receive the output of the coupler 140 so as to generate at least one signal indicative of sensed optical property or properties of the reflected light. The at least one signal generated by the optical property sensing logic 515 may be provided to the optical property determining logic 516, which may determine at least one property (e.g., at least one optical property) of the region 506 based on the at least one signal provided by the optical property sensing logic 515. The at least one property of the region 506 may include at least one of a transmittance of the region 506, a reflectance of the region 506, an absorbance of the region 506, a scattering coefficient of the region 506, and an intensity of the reflected light within a spectrum. For example, the optical property sensing logic 515 and the optical property determining logic 516 may use changes in intensity of reflected light to determine the reflectance of the region 506. Other example ways of receiving the output of the coupler 140 so as to determine the at least one property of the region 506 will be understood by those of skill in the art after understanding the present disclosure.
The optical property determining logic 516 may send information regarding the determined at least one property of the region 506 to the material type determining logic 518. In some embodiments, the optical property determining logic 516 may also or alternatively send information regarding the determined at least one property to the material distance determining logic 520. The material type determining logic 518 may determine, based on the information from the optical property determining logic 516, the type of the material in the region 506. As just one example, the material type determining logic 518 may analyze the determined at least one property of the region 506 within the vascular system by analyzing diffuse absorbance and transmittance (DAAT) characteristics of the region 506 as determined by the optical property determining logic 516 to determine that the type of the material in the region 506 comprises biological material and, more particularly, that the type of the material comprises one of blood or tissue.
In other embodiments, the analysis by the material type determining logic 518 may further indicate that the type of the material in the region is biological material, for example, a particular cell type or biomolecule associated with the cells of a particular tissue, such as SVC tissue, which may be particularly useful in assisting a clinician in avoiding dangerous SVC tears when performing ablation using the laser catheter 170. In still further examples, the material type determining logic 518 may determine that the type of the material in the region 506 comprises non-biological material, such as, for example, fat deposits (e.g., cholesterol monohydrate, cholesterol esters and phospholipids), fibrous tissue (e.g., fibrin, proteoglycans, collagen), calcium deposits (e.g., calcium oxide, calcium carbonate, calcium phosphates), and remnants of dead cells and cellular debris in the region 506, etc.
As discussed above, the optical property determining logic 516 may also or alternatively send the information regarding the determined at least one property of the region 506 within the vascular system of the patient to the material distance determining logic 520. The material distance determining logic 520 may determine, based on the information from the optical property determining logic 516, an indication of a distance to the material in the region 506 within the vascular system. For example, the material distance determining logic 520 may cause the at least one controller 180 to generate an indication (e.g., via the I/O device(s) 512) that the distance to the material in the region 506 is shorter than desired based on the determined type of the material in the region (e.g., based on determining that the type of the material in the region 506 is SVC tissue, the at least one controller 180 may generate an indication of a risk of causing an SVC tear given the distance to the SVC). The material distance determining logic 520, and/or the material type determining logic 518, may also determine whether the material in the region 506 is a proper target for laser ablation (e.g., based on the type of the material in the region 506 and/or the distance to the material in the region 506). For example, if the material distance determining logic 520 indicates that the laser catheter 170 is in dangerously close contact with the SVC, the material distance determining logic 520 may determine that the material in the region 506 is not a proper target for ablation.
The material type determining logic 518 and the material distance determining logic 520 may also or alternatively be configured to cause the at least one controller 180 to generate, such as via the I/O device(s) 512, an alert based on the determined type of the material in the region 506 and/or the determined distance to the material. The alert may, for example, prompt a clinician to adjust an intensity of, or power off, the light source (e.g., laser source 500 or diagnostic light source 502).
In accordance with an embodiment of the present disclosure, the material type determining logic 518 and/or the material distance determining logic 520 may analyze the information from the optical property determining logic 516 (e.g., determined transmittance, reflectance, absorbance, and/or scattering coefficient of the region 506) with respect to a library of information regarding different types of materials and/or distances to materials in order to determine material type and/or indication of distance, respectively. The library of information may, in one embodiment, be contained within the at least one memory 510, and may comprise any suitable executable instructions or other content within memory to allow the material type determining logic 518 and/or the material distance determining logic 520 to determine material type in the region 506 and/or indication of distance to the material in the region 506. The information from the optical property determining logic 516 regarding the determined at least one property of the region 506 may, for example, be compared against information in the library to determine the type of the material in the region 506 and/or the distance to the material.
Furthermore, in accordance with an embodiment of the present disclosure, the optical property determining logic 516 may receive the output of the coupler 140 so as to determine at least one property of the region 506 on a fiber-by-fiber basis. That is, the optical property determining logic 516 may determine the at least one property individually for each of the return fibers 302, thus allowing the determining of the type of the material in the region 506 and/or the indication of the distance to the material in the region 506 to be performed/provided for each individual one of the fibers 302. Such individualized determinations may be useful when, for example, the laser catheter 170 is contacting blood or tissue at an angle and thus the characteristics of reflected light at each of the return fibers 302 are different (see, e.g., discussion of
Turning now to
More specifically, the group 800 of video frames shows example intensities of a red channel 810, a green channel 812, and a blue channel 814 for each of the return fibers 802, 804, 806, and 808 and example corresponding indications of type of a material and/or distance to a material. For example, along the horizontal (time) axis, indication 816 shows that a catheter tip (e.g., a tip of laser catheter 170) is contacting an exposed vessel within the vascular system of a patient. Indication 818 shows that the catheter tip is in blood; indication 820 shows that the catheter tip is in the SVC; indication 822 shows that the catheter tip is moving along the SVC; indications 824 and 826 show that the catheter tip is in blood; indication 828 may alert a clinician to move or push the catheter to the left; indication 830 may alert the clinician to move or push the catheter to the right; indication 832 may alert the clinician to move or push the catheter up; indication 834 may alert the clinician to move or push the catheter down; and indication 836 may alert the clinician that the catheter tip is in blood. It will be appreciated upon review of the present disclosure that the waveforms of intensities of the red, green, and blue channels 810, 812, and 814, and the corresponding indicators 816-836, are not necessarily indicative of the conditions that may exist in a particular application, as such intensities and conditions may depend upon a number of factors such as characteristics of the catheter employed, fiber characteristics, etc.
As to
As shown in block 902, the method may also include determining (e.g., by the optical property determining logic 516) at least one property of the region within the vascular system from the reflected light from the region.
As shown in block 904, the method may also include determining (e.g., by the material type determining logic 518) a type of a material in the region within the vascular system based on determining the at least one property from the reflected light.
As shown in block 906, the method may also include determining (e.g., by the material distance determining logic 520) an indication of a distance to the material in the region within the vascular system based on determining the at least one property from the reflected light. The method may then end and may be repeated as needed or desired.
As shown in block 1002, the method may also include supplying diagnostic light to a region (e.g., 506) containing the unwanted blockage/deposits using at least one source fiber (e.g., 300) of the laser catheter.
As shown in block 1004, the method may include receiving light reflected from the region containing unwanted blockage/deposits using at least one return fiber (e.g., 302) of the laser catheter 170.
As shown in block 1006, the method may also include determining at least one property (e.g., by the optical property sensing logic 515 receiving the output of the coupler 140 and generating at least one signal indicative of a sensed property of the reflected light, and by the optical property determining logic 516 determining the at least one property based on the signal generated by the optical property sensing logic 515) of the region containing the unwanted blockage/deposits from the reflected light.
As shown in block 1008, the method may include determining a type of a material in the region and/or an indication of a distance to the material in the region (e.g., by the material type determining logic 518 and/or the material distance determining logic 520) based on determining the at least one property of the region.
As shown in block 1010, the method may also include generating an indication (e.g., by the I/O device(s) 512) that an intensity of the light source is to be adjusted, that the light source is to be turned off, and/or that the laser catheter is to be moved further from the material in the region. Alternatively, an indication may be generated that the laser catheter is to be moved closer to the material in the region. The indication may be generated based on the determination(s) made in block 1008.
As shown in block 1012, the method may also include controlling the light source and/or controlling the positioning of the laser catheter 170 based on the generated indication (e.g., block 1010). The method may then end and may be repeated as needed or desired.
Through the use of techniques such as those described above to determine a type of a material in a region within the vascular system, and an indication of a distance to such material, selective ablation of the fatty core 1308 may be achieved. Based on a determined type of a material and/or indication of distance to such material, the buildup 1304 and the fatty core 1308 may be identified and the at least one source fiber 300 may ablate a portion of the buildup 1304 so as to create an entry path 1310 into the fatty core 1308. Lasing may then cause the fatty core 1308 to ablate, and the resulting ablated plaque may pass through an exit path 1312. A guidewire 1314 may hold the laser catheter 170 in a position so as to perform the ablation and so that the ablated plaque that passes through the exit path 1312 is collected with a downstream occlusion filter 1316 that ensures, for example, that the ablated plaque does not mix into the bloodstream of the patient.
As shown in
It will be appreciated that various modifications of the embodiments herein may be made after review of and understanding of the present disclosure. For example, different fiber tip geometries may be used to change the treatment and/or diagnostic areas as desired, and/or to control the gathering of reflected light. Diagnostic light source intensity may also be varied to more accurately reveal geometric features of tissues in some cases. Fluorescence and/or mitochondrial markers may be employed to discriminate tissue types, such as using mitochondrial markers to distinguish between live tissue and scar tissue. Force/strain measurements may be made using a diffraction grating (e.g., a Bragg diffraction grating) along the laser catheter 170 or its tip, or using interferometry-based microelectromechanical systems (MEMS) sensors. Force sensors may also be used to infer or determine tissue type, including whether tissue is comprised of biological material or non-biological material.
It will be further appreciated upon review of the disclosure that the example features and methods described herein thus allow ablation of unwanted blockage, deposits, etc. in a peripheral artery or, in a similar procedure, surrounding an electrical lead. In the case of an electrical lead, the lead itself may then be removed.
A number of variations and modifications of the disclosure can be used. It would be possible to provide for some features of the disclosure without providing others. Furthermore, embodiments of systems and methods according to the present disclosure may include and/or be used in conjunction with any of the systems, devices, structures, and/or methods described in U.S. patent application Ser. Nos. 13/800,651, 13/800,675, 13/800,700, and/or 13/800,728, all of which were filed on Mar. 13, 2013, the disclosures of which are hereby incorporated by reference in their entireties.
The present disclosure, in various aspects, embodiments, and configurations, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various aspects, embodiments, configurations, sub-combinations, and subsets thereof. Those of skill in the art will understand how to make and use the various aspects, aspects, embodiments, and configurations, after understanding the present disclosure. The present disclosure, in various aspects, embodiments, and configurations, includes providing devices and processes in the absence of items not depicted and/or described herein or in various aspects, embodiments, and configurations hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and/or reducing cost of implementation.
The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more, aspects, embodiments, and configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and configurations of the disclosure may be combined in alternate aspects, embodiments, and configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspects, embodiments, and configurations. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
Moreover, though the description of the disclosure has included description of one or more aspects, embodiments, or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
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| Number | Date | Country | |
|---|---|---|---|
| 20160183804 A1 | Jun 2016 | US |
